Luvena Vaginal Moisturizer and Lubricant is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.

Device Description

Luvena Vaginal Moisturizer & Lubricant is non-sterile, translucent, non-staining, non-greasy, aqueous-based, cranberry-flavored gel and is packed in EVA/PE copolymer plastic applicator tube. Each application tube is single-use. It is for personal vaginal use as need for moisturizing and lubrication during intimate sexual activity. This device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to ASTM D7661-10.

AI/ML Overview

This document is a 510(k) Summary for the Luvena Vaginal Moisturizer & Lubricant (K162235). The primary purpose of this summary is to demonstrate substantial equivalence to a predicate device, not to provide a detailed study for meeting specific acceptance criteria in the context of an AI/algorithm-based medical device. Therefore, much of the requested information regarding AI device evaluation is not directly available in this text.

However, I can extract information related to the device's specifications and the testing performed to ensure its safety and effectiveness, which can be interpreted as fulfilling certain acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a personal lubricant, the "acceptance criteria" are related to its physical properties, microbial safety, biocompatibility, and compatibility with condoms.

Acceptance Criteria Category	Specific Criteria / Test	Reported Device Performance
Physical Properties	Appearance, Odor, pH, Viscosity, Osmolality	Appearance: non-sterile, translucent, non-staining, non-greasy Odor: Cranberry-flavored gel pH: 3.8 - 4.8 (Matches predicate) Viscosity, Osmolality: Evaluated (Specific values not provided, but implicitly met specifications)
Microbiological Safety	Total Aerobic Microbial Count (TAMC) (USP <61> and <1111>)Total Yeast and Mold Count (TYMC) (USP <61> and <1111>)Absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans (USP <62>))	Met specifications as recommended in USP <1111> for vaginal use products. Also passed Antimicrobial Preservative Effectiveness Validation testing under USP <5> Category 2.
Biocompatibility	Cytotoxicity (ISO 10993-5:2009)Sensitization (ISO 10993-10:2010 - GPMT)Vaginal Irritation (ISO 10993-10:2010)Acute Systemic Toxicity (ISO 10993-11:2006)	The results demonstrate that the subject lubricant is biocompatible.
Condom Compatibility	Compatibility with natural rubber latex and polyisoprene condomsIncompatibility with polyurethane condoms (ASTM D7661-10)	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. (Matches predicate and tested per ASTM D7661-10)
Shelf Life	Stability testing (ICH-Q1A, ICH-Q1E)	Results of accelerated time testing and real-time testing support the proposed shelf life. (Specific shelf life duration not provided but implied as adequate).

2. Sample Size for Test Set and Data Provenance

This document does not describe a "test set" in the context of an AI/algorithm evaluation. The testing described falls under laboratory and in vitro testing for a physical product (lubricant). Therefore, information on "country of origin of data" or "retrospective/prospective" does not apply in the typical sense for AI devices. The sample sizes for the various physical, chemical, and biological tests performed on the lubricant formulation are not specified in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. "Experts" in this context would be laboratory technicians and chemists performing the tests according to established standards (ISO, USP, ASTM). There isn't a "ground truth" to be established by human experts in the way it would be for an AI device.

4. Adjudication Method

Not applicable, as there is no "adjudication" in the context of expert review for an AI device. The tests are laboratory-based and yield objective results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI device, so there is no comparison of human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a physical device (lubricant), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" in this context is established by:

Established standards: ISO, USP, and ASTM test methods define the benchmarks against which the lubricant's properties (biocompatibility, microbial limits, condom compatibility) are measured.
Laboratory measurements: Objective physical, chemical, and biological assays directly determine the characteristics of the product.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/algorithm device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2017

Laclede, Inc. Michael Pellico President 2103 E. University Dr. Rancho Dominguez, CA 90220

Re: K162235

Trade/Device Name: Luvena Vaginal Moisturizer and Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 21, 2017 Received: February 24, 2017

Dear Michael Pellico:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K162235

Device Name

Luyena Vaginal Moisturizer and Lubricant

Indications for Use (Describe)

Luyena Vaginal Moisturizer and Lubricant is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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510 (k) Summary

Submission By:	Laclede, Inc.
Address:	2103 E. University DriveRancho Dominguez, Ca 90220
Telephone:	310-605-4280
Facsimile:	310-605-4288
Contact Name:	Michael A. Pellico, President
Email:	mpellico@laclede.com

Date 510(k) Summary Prepared: March 23, 2017

Trade Name:	Luvena Vaginal Moisturizer & Lubricant
Common Name:	Personal Lubricant
Classification Name:	Condom (21 C.F.R. 884.5300)
Classification:	Class II
Product Code:	NUC (lubricant, personal)

Primary Predicate Device:

Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant: K150841, Laclede, Inc. This predicate device has not been subject to any design related recall.

Device Description:

This device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to ASTM D7661-10.

Device Specifications:

The device specifications for the Luvena Vaginal Moisturizer and Lubricant include appearance, odor, pH, viscosity, osmolality, Total Aerobic Microbial Count ((TAMC) (USP<61> and <1111>)), Total Yeast and Mold Count ((TYMC) (USP<61> and <1111>)), and absence of pathogenic organisms ((Pseudomonus aeruginosa, Staphylococcus aureus, Candida albicans (USP<62>)). These specifications were evaluated during the length of the proposed shelf life.

Intended Use:

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natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.

Substantial Equivalence:

Luvena Vaginal Moisturizer & Lubricant have the same intended use as the predicate device. However, the subject moisturizer & lubricants and the predicate device have different technological characteristics – namely differences in viscosity, formulation and package type. These differences do not raise different questions of safety & effectiveness.

Features	Luvena VaginalMoisturizer &Lubricant	Luvena Enhanced PersonalMoisturizer andLuvena Enhanced PersonalLubricantK150841	Differences
Water Based	Yes	Yes	Same, The subject andpredicate device are waterbased
Water Soluble	Yes	Yes	Same, The subject andpredicate device are soluble inwater
Non Sterile	Yes	Yes	Same, The subject andpredicate device are non-sterile.
Flavoring	Cranberry	Cranberry	Same, The subject andpredicate device have sameflavoring.
Container Type	Single use Applicator	Bottle with pump	The subject and predicatedevice are different size andshape for OTC packaging, butthese differences have noimpact on the safety or efficacyof the personal lubricant.
Condomcompatibility	YesASTM D7661-10Compatible withnatural rubber latexand polyisoprenecondoms, and notcompatible withpolyurethanecondoms.	YesASTM D7661-10Compatible with naturalrubber latex andpolyisoprene condoms, andnot compatible withpolyurethane condoms.	Same, The subject andpredicate device have beentested for condom compatibilityin accordance with ASTMD7661-10.
pH	Yes3.8 - 4.8	Yes3.8 - 4.8	Same, The subject and predicatedevice have same pH range.
MicrobiologicalExamination ofNon-sterileProducts Testing	USP <61>/<62>	USP <61>/<62>	Same, The subject and predicatedevice have been tested forMicrobial Limit test inaccordance with USP <61> and<62> and have samespecifications as recommendedin USP<1111> for vaginal use
		products.
Body LocationTarget area	Vaginal application	Penile and/orVaginal application	Same, Subject and predicate device are for Vaginal application.
Intended Use	Moisturize & Lubricate during sexual activity	Moisturize & Lubricate during sexual activity	Same, Subject and predicate device have same intended use.

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Biocompatibilitv:

Biocompatibility of the final formulation of Luvena Vaginal Moisturizer & Lubricant was established through testing generally following ISO 10993, and includes cytotoxicity, sensitization, irritation, and acute systemic toxicity testing. The results demonstrate that the subject lubricant is biocompatible.

· Acute Systemic Toxicity: ISO 10993-11:2006
· Cytotoxicity: ISO 10993-5:2009
· Vaginal Irritation Testing: ISO 10993-10:2010
· Sensitization Testing Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010.

Physical & Other Testing:

The physical and other testing performed on Luvena Vaginal Moisturizer & Lubricant included an Antimicrobial Preservative Effectiveness Validation testing under USP < 5 > Category 2. Lubricant- Condom Compatibility testing per ASTM D7661 - 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms and Shelf life testing. Luvena Vaginal Moisturizer and Lubricant passed the Antimicrobial Effectiveness test and were found to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms. The results of accelerated time testing and real time testing according to ICH-Q1A (Stability testing of new drug substances and products) and ICH-Q1E (Evaluation of stability data) support the proposed shelf life for the subject lubricant.

Conclusion:

The subject and predicate device have the same intended use and the different technological characteristics do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.